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Bioniche Life Science (TSX:BNC)

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Last Post: 3/13/2010 3:42:18 PM - Followers: 0 - Board type: Free - Posts Today: 0

Bioniche Life Science (BNC.TO) MarketCap 33 Mio C$ Price 0,38 C$ Upcoming Milestones : Bladder Cancer PIII Update in July US approval for E.coli Vaccine in August or September 2009 Econiche - World's First Cattle Vaccine to Reduce E. coli O157 Gets Approval in Canada "While Epitopix may have the first product of its kind in the United States, others have plans to follow. Bioniche Life Sciences Inc. of Canada is also working on getting a USDA conditional license for a vaccine and hopes to have approval by August or September, said Gary Weber, president of food and safety for the firm's U.S. division. " Bioniche Phase III Clinical Trial with Urocidin(TM) Progressing Well * Press Release * Source: Bioniche Life Sciences Inc. * On Friday May 22, 2009, 4:00 pm EDT * Buzz up! 0 * Print BELLEVILLE, ON, May 22 /CNW/ - Bioniche Life Sciences Inc. ("Bioniche"; TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today provided an update on its Phase III clinical program evaluating Urocidin(TM) in the treatment of bladder cancer. On March 31st, the Company announced that recruitment had been completed in its initial Phase III registration trial evaluating Urocidin in the treatment of non-muscle-invasive bladder cancer that is refractory (unresponsive) to the current standard immunotherapy - Bacillus Calmette-Guérin (BCG). The Data Safety Monitoring Committee (DSMC) held its eighth meeting regarding this clinical trial earlier this week. After its meeting, the Committee has recommended that Bioniche "continue the trial unmodified until the next scheduled or triggered meeting." The next scheduled meeting of the Committee is July. The DSMC is an independent group that acts in an advisory capacity to the Company. Its role is to evaluate the progress of the clinical trial, including monitoring the safety and efficacy data generated in the trial. On a regular basis, the DSMC reviews study results, evaluates the incidence of adverse events, determines whether the basic trial assumptions remain valid, and evaluates whether the overall integrity, scientific merit and conduct of the study remain acceptable. Data from the full cohort of 105 high-grade bladder cancer patients from this trial, coupled with additional safety information to be collected from a second clinical trial that is expected to start later this year, will be used to support regulatory submissions under the FDA's Accelerated Approval program. Second Phase III Registration Trial Bioniche plans to conduct a second registration trial that will directly compare the efficacy and safety of Urocidin with BCG in the first-line treatment of non-muscle-invasive bladder cancer. In September, 2007, the Company announced that an agreement had been reached with the FDA under the Special Protocol Assessment (SPA) procedure on the design of the trial, including its endpoints, data analysis and conduct. It provides assurance that, if the trial endpoints are met, they will serve as the basis for product approval under a Biologics Licensing Application (BLA). An SPA gives a clear pathway to registration of Urocidin when the trial endpoints are achieved. This indication for MCC received Fast Track designation by the FDA last year. The Company expects to start this trial at such time as it has a development and marketing partner in place.
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#24   ***** DONT MISS THE BIG OPPORTUNITY ***** DollerHero 03/13/10 03:42:18 PM
#23   Nice Research by Crystal DollerHero 02/19/10 01:43:06 PM
#22   BNC.TO is the next Dendreon !!!!!!!!!!! BioSpecialist 02/15/10 06:51:40 PM
#21   Fantastic News out for Bioniche !!!! BioSpecialist 02/12/10 11:19:36 AM
#20   RAALLLYYYY ..PIII Results Soon !!!!! BioSpecialist 01/26/10 11:27:27 AM
#19   Phase III Data will be positive BioSpecialist 01/25/10 01:52:41 PM
#18   1,50 $ TGT by Haywood BioSpecialist 01/13/10 06:42:04 AM
#17   BNC is up 17% BioSpecialist 01/12/10 12:32:36 PM
#16   The best and cheapest canadian biotech company ... BioSpecialist 01/12/10 10:47:04 AM
#15   BREAK OUT WILL HAPPEN SOON !!! BioSpecialist 10/06/09 02:19:44 PM
#14   Bioniche Phase III Clinical Trial with Urocidin(TM) Given BioSpecialist 08/25/09 12:10:19 PM
#13   What a great Opportunity !!! BioSpecialist 08/19/09 03:25:57 PM
#12   BNC.TO ..Outperform Rating BioSpecialist 07/19/09 09:59:38 AM
#11   Upcoming Milestones BioSpecialist 07/17/09 05:35:25 AM
#10   Great Article .. BioSpecialist 07/17/09 05:30:25 AM
#9   Very nice....any guess what it is worth, where learning as I go 07/12/09 10:02:26 AM
#8   Fantastic News boooyaahhh BioSpecialist 07/10/09 08:17:31 AM
#7   So is this a startup? I can't buy anything. usmcallen 07/09/09 01:01:11 PM
#6   CMO is optimistic for MCC in Bladder Cancer BioSpecialist 07/08/09 06:25:15 AM
#4   bid .0001 at this stage! Ask .0001 bigdaddy2 07/07/09 06:45:06 PM
#3   More active message board BioSpecialist 07/07/09 04:39:25 PM
#1   iHub ticker is TSX:BNC Stock 07/07/09 07:36:38 AM